Teva-Escitalopram (Teva Canada, 5 mg, 15 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What is the medication used for:

TEVA-ESCITALOPRAM has been prescribed to you by your doctor to relieve your symptoms of depression. Treatment with these types of medications is most safe and effective when you and your doctor have good communication about how you are feeling.

What it does:

TEVA-ESCITALOPRAM belongs to a group of medicines known as antidepressants, more specifically to the family of medicines called SSRIs (Selective Serotonin Reuptake Inhibitors).

TEVA-ESCITALOPRAM is thought to work by increasing the levels of a chemical in the brain called serotonin (5-hydroxytryptamine).

When it should not be used:

• Do not use TEVA-ESCITALOPRAM at the same time as

  pimozide.

• Do not use TEVA-ESCITALOPRAM if you are currently or

  have recently taken monoamine oxidase anti-depressants (e.g. phenelzine sulphate, moclobemide).

• Do not take TEVA-ESCITALOPRAM if you are allergic to

  it, or to any of the components of its formulation.

• Stop taking TEVA-ESCITALOPRAM and contact your

  doctor immediately if you experience an allergic reaction or any severe side effect.

What the medicinal ingredient is:

Escitalopram oxalate

What the important nonmedicinal ingredients are:

Colloidal silicon dioxide, croscarmellose sodium, glycerol triacetate, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, stearic acid, titanium dioxide and triacetin

What dosage forms it comes in:

Tablet: 5 mg, 10 mg, 15 mg & 20 mg.

WARNINGS AND PRECAUTIONS

Treatment with these types of medications is most safe and effective when you and your doctor have good communication about how you are feeling.

TEVA-ESCITALOPRAM is not for use in children under 18 years of age.

New or Worsened Emotional or Behavioral Problems

Particularly in the first few weeks or when doses are adjusted, a small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of self-harm or harm to others. Should this happen to you, or to those in your care if you are a caregiver or guardian, consult your doctor immediately. Close observation by a doctor is necessary in this situation. Do not discontinue your medication on your own.

Effects on Pregnancy and Newborns

Possible complications at birth (from taking any newer antidepressant, including TEVA-ESCITALOPRAM):

Post-marketing reports indicate that some newborns whose mothers took an SSRI (Selective Serotonin Reuptake Inhibitor) such as TEVA-ESCITALOPRAM or other newer antidepressant during pregnancy have developed complications at birth requiring prolonged hospitalisation, breathing support and tube feeding. Reported symptoms include: feeding and/or breathing difficulties, seizures, tense or overly relaxed muscles, jitteriness and constant crying. In most cases, the newer antidepressant was taken during the third trimester of pregnancy. These symptoms are consistent with either a direct adverse effect of the antidepressant on the baby, or possibly a discontinuation syndrome caused by sudden withdrawal from the drug. These symptoms normally resolve over time. However, if your baby experiences any of these symptoms, contact your doctor as soon as you can.

Persistent Pulmonary Hypertension (PPHN) and newer antidepressants:

Preliminary information suggests that use of SSRIs during the second half of pregnancy may be associated with an increased rate of a serious lung condition (PPHN) that causes breathing difficulties in newborns soon after birth. According to the study, babies born with this condition were 6 times more likely than healthy babies to have been exposed to SSRIs. In the general population, PPHN is known to occur at a rate of about 1-2 per 1000 newborns.

If you are pregnant and taking an SSRI, or other newer antidepressant, you should discuss the risks and benefits of the various treatment options with your doctor. It is very important that you do NOT stop taking these medications without first consulting your doctor.

Before you use TEVA-ESCITALOPRAM, tell your doctor:

• All your medical conditions, including heart problems,

  history of seizures, manic-depressive illness, liver or kidney disease, diabetes or history of bleeding disorders.

• Any medications (prescription or non-prescription) which

  you are taking or have taken within the last 14 days, especially monoamine oxidase inhibitors, pimozide, any other antidepressants, triptans used to treat migraines, lithium, tramadol or drugs containing tryptophan.

• If you ever had an allergic reaction to any medication or any

  of the ingredients mentioned in this leaflet.

• If you are pregnant or thinking of becoming pregnant, or if

  you are breastfeeding.

• Your habits of alcohol consumption.

• If you drive a vehicle or perform hazardous tasks during your

  work.

INTERACTIONS WITH THIS MEDICATION

Serious Drug Interactions

• Monoamine oxidase inhibitor (e.g., phenelzine,

  tranylcypromine, moclobemide or selegiline)

• Pimozide
• Linezolid (an antibiotic)

Other drugs that may interact with TEVA-ESCITALOPRAM include:

• Other SSRI’s (citalopram) or any other antidepressant (e.g.,

  imipramine, desipramine)

• Lithium
• Tryptophan
• Cimetidine
• Triptans (e.g., sumatriptan, zolmitriptan, naratriptan)
• Tramadol
• Fluconazole
• Ketoconazole
• Itraconazole
• Racemic Citalopram
• Erythromycin
• Warfarin
• Omeprazole
• Any herbal product such as St. John’s Wort

• Any medicine that affect the rate of clotting of the blood e.g.,

  acetylsalicylic acid (ASA) or non-steroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen, naproxen, etc. and phenothiazines such as chlorpromazine.

Avoid drinking alcohol while taking TEVA-ESCITALOPRAM.

Drugs from the class that TEVA-ESCITALOPRAM belongs to may increase the chance of a bleeding event such as nose bleeds, bruising and even life threatening bleeding. This is more likely if you have a history of a bleeding disorder or are taking other drugs that are known to affect your platelets.

Treatment with an SSRI in patients with diabetes may alter glycaemic control (hypoglycaemia and hyperglycaemia).

Tell your doctor all the medicines (prescription or over the counter) that you are using or thinking of taking.

PROPER USE OF THIS MEDICATION

Usual dose:

• It is important that you take TEVA-ESCITALOPRAM exactly as your doctor has instructed.
• Usually your doctor will prescribe 10 mg per day, which you will take once daily preferably at the same time each day. If you are elderly, your doctor may prescribe a lower dose. This dose may be increased. Never change the dose of TEVA-ESCITALOPRAM you are taking, or that someone in your care is taking unless your doctor tells you to.

• Swallow the tablets whole with a drink of water. Do not chew them. TEVA-ESCITALOPRAM can be taken with or without food.

• You should continue to take TEVA-ESCITALOPRAM even if you do not feel better, as it may take several weeks for your medication to work. Improvement may be gradual.
• Continue to take TEVA-ESCITALOPRAM for as long as your doctor recommends it. Do not stop taking your tablets abruptly even if you begin to feel better, unless you are told to do so by your doctor. Your doctor may tell you to continue to take TEVA-ESCITALOPRAM for several months. Continue to follow your doctor’s instructions.

Overdose:

If you have accidentally taken too much TEVA-

ESCITALOPRAM, contact your doctor or nearest hospital emergency department immediately, even if you do not feel sick. If you go to the doctor or the hospital, take the TEVA-ESCITALOPRAM container with you.

Missed Dose:

If you miss a dose, do not worry. Do not take the missed tablet(s) -just take the next dose when it is due.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

• TEVA-ESCITALOPRAM may cause unwanted effects (side-effects). These may include nausea, increased sweating, In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. diarrhoea, fatigue, fever, constipation, clogged or runny nose, sleep disturbance, loss of appetite, decreased interest in sex, decreased ability to reach orgasm, erectile dysfunction, difficulties falling asleep, drowsiness, yawning, dizziness, dry mouth, heartburn, stomach pain and changes in heart rate.

• Particularly in the first few weeks or when doses are adjusted, a small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of self-harm or harm to others. Should this happen to you, or to those in your care if you are a caregiver or guardian, consult your doctor immediately;

  do not discontinue your medication on your own.

• Contact your doctor before stopping or reducing your dosage of escitalopram. Symptoms such as dizziness, abnormal dreams, electric shock sensations, agitation, anxiety, emotional indifference, difficulty concentrating, headache, migraine, tremor (shakiness), nausea, vomiting, sweating or other symptoms may occur after stopping or reducing the dosage of escitalopram. Such symptoms may also occur if a dose is missed. These symptoms usually disappear without needing treatment. Tell your doctor immediately if you have these or any other symptoms. Your doctor may adjust the dosage of escitalopram to reduce the symptoms.
• Side-effects are often mild and may disappear after a few days. If they are troublesome or persistent, or if you develop any other unusual side-effects while taking TEVA-ESCITALOPRAM, please consult your doctor.
• Usually TEVA-ESCITALOPRAM does not affect your ability to carry out normal daily activities. However, you should not drive a car or operate machinery until you are reasonably certain that TEVA-ESCITALOPRAM does not affect you adversely.

• Postmarketing reports indicate some newborns whose mothers took an SSRI (Selective Serotonin Reuptake Inhibitor) such as TEVA-ESCITALOPRAM or other newer antidepressant during pregnancy have developed complications at birth requiring prolonged hospitalisation, breathing support and tube feeding. Reported symptoms include: feeding and/or breathing difficulties, seizures, tense or overly relaxed muscles, jitteriness and constant crying. In most cases, the newer antidepressant was taken during the third trimester of pregnancy. These symptoms are consistent with either a direct adverse effect of the antidepressant on the baby, or possibly a discontinuation syndrome caused by sudden withdrawal from the drug. These symptoms normally resolve over time. However, if your baby experiences any of these symptoms, contact your doctor as soon as you can.

  If you are pregnant and taking an SSRI, or other newer antidepressant, you should discuss the risks and benefits of the various treatment options with your doctor. It is very

  important that you do NOT stop taking these medications without first consulting your doctor.

  SERIOUS SIDEEFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

*If you think you have these side effects, it is important that you seek medical advice from your doctor immediately.

This is not a complete list of side effects. For any unexpected effects while taking TEVA-ESCITALOPRAM, contact your doctor or pharmacist

HOW TO STORE IT

• As with all medicines, keep TEVA-ESCITALOPRAM out of

  the reach of children. Store your tablets at room temperature (15° - 30°C) in a dry place.

• Keep the container tightly closed.

• There is an expiry date on the label. Do not use the medicine

  after this date.

• If your doctor tells you to stop taking your medicine you

  should return any leftover tablets to the pharmacist, unless the doctor tells you to keep them at home.

REMEMBER: This medicine is for YOU. Only a doctor can prescribe it, so never offer it to any other person, even if their symptoms seem to be the same as yours.

CTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to:

    Canada Vigilance Program

    Health Canada

    Postal Locator 0701D

    Ottawa, Ontario

    K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at

www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting, Teva Canada Limited:

at: 1-800-268-4127 ext. 5005 (English); 1-877-777-9117 (French)

or druginfo@tevacanada.com

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Date of Preparation: September 23, 2010